The European Medicines Agency announced that it will “accelerate” its assessment of the possible relationship between Janssen’s vaccine against covid-19 and “very rare” thrombotic cases
Madrid (EUROPA PRESS)-The European Medicines Agency (EMA) announced that it is “accelerating” its assessment of the possible relationship between Janssen’s vaccine against covid-19 and “very rare” cases of low platelet thrombosis, he said Hope to post suggestions next week.
In any case, although European regulators recalled that the review was “still ongoing,” EMA stated that “it still believes that the benefits of the vaccine against covid-19 outweigh the risks of side effects.
Currently, he announced that “he is investigating all reported cases and will decide whether it is necessary to take regulatory measures.”
He added: “It is working closely with the US FDA and other international regulatory agencies.”
The United States yesterday recommended to stop using the vaccine, and at the same time reviewed 6 thrombosis cases among more than 6.8 million people who received the vaccine.
The type of thrombus reported was cerebral venous sinus thrombosis (CVST), which in most cases combined with low levels of platelets (thrombocytopenia).
Similarly, Janssen announced yesterday that it has decided to actively postpone the launch of the vaccine in Europe while the investigation continues. The biological product was approved in the European Union on March 11, but it has not yet been widely used in Europe.
According to EMA, the company is “contacting” with national authorities to recommend storing the doses that have been received until the EMA’s safety committee PRAC makes a recommendation.